Comparing Pain and Swelling After Surgical Extraction of Mandibular Third Molar in Dexamethasone Injection and Without Corticosteroid Methods

Phase 4

• Conditions: Oral Health; Molar, Third
• Interventions: Drug: 21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione

• Registration Number: NCT01896427
• Lead Sponsor: Mohammad Javad Shirani

Brief Summary

In some cases, impacted wisdom teeth should be extracted. Surgical extraction of these impacted third molars may provide special complication as pain, swelling, and trismus. In previous studies, some techniques as sutureless flap closure, modified flap designing, antibiotic usage, and injection of corticosteroids were presented. These methods are reducing post operative complications to moderate level. In this study, pain, swelling, trismus, general patients' satisfaction, and associated quality of life after the surgical removal of third mandibular impacted molars will be compared while injection of dexamethasone (8mg) does not need excessive time, effort, and equipments and it will be injected in numbness area into medial pterygoid muscle and pterygomandibular space to current corticosteroid injecting non-corticosteroid methods. To achieve this aim, 75 non pregnant participants have single impacted mandibular third molar in healthy and without pericoronitis manner, after provision of written informed consent will be entered to the study. During the study, unwilling participants to continue the study and those with abnormality of wound healing process will be excluded. The included participants will be assigned into three 25-people groups. The surgeries were done by 3 same instructed experienced oral and maxillofacial residents. After the surgery pain, swelling, trismus, general patients' satisfaction, and associated quality of life were evaluated using interview of questionnaire in 48 hour, 96 hour, and one week period of time. The comparison was done between these three groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-06-30
• Status Verified: 2013-07
• Study First Submitted QC: 2013-07-06
• Last Update Submitted: 2013-07-06
• Study First Posted: 2013-07-11
• Last Update Posted: 2013-07-11
• Primary Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Non pregnant participants have single impacted mandibular third molar in healthy and without pericoronitis manner
• They must have no contra-indication for injection of the corticosteroid and lidocaine with epinephrine
• Should not medicated by any possibly bias maker drug
• Type of the impaction, must not provide sever difficulty
• The participants should be mentally at healthy level and provide written informed consent to incorporate in the study

Exclusion Criteria

-Unwilling participants to continue the study and those with abnormality of wound healing process

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethazone IO	21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione	For the case group, after the inferior alveolar block injection and before starting the surgery, single dose of dexamethasone (8mg) will injected into medial pterygoid and pterygomandibular space
Dexamethasone IM	21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione	For the case group, after the inferior alveolar block injection and before starting the surgery, single dose of dexamethasone (8mg) will injected into medial pterygoid and pterygomandibular space

Primary Outcome Measures

Name	Time	Method
Changes in Pain	48 hours and one week after intervention	Visual analogue scale of pain- Number of required analgesics tablets
Changes in Swelling	48 hours and one week after intervention	Questionnaire and VAS
Changes in Trismus	48 hours and one week after intervention	Questionnaire
Changes in General patients' satisfaction	48 hours and one week after intervention	Visual analogue scale for satisfaction
Changes in Quality of life	96 hours and one week after intervention	Questionnaire

Secondary Outcome Measures

Name	Time	Method
Trismus	one week period after the surgery	Questionnaire about Maximum mouth opening- Patients complaint

Trial Locations

Locations (1)

Department of oral and maxillofacial surgery, Faculty of Dentistry, Isfahan University of Medical Sciences; 🇮🇷 Isfahan, Iran, Islamic Republic of